Ovesco Endoscopy AG

Address:Friedrich-Miescher-Strasse 9,Tuebingen Baden-Wurttemberg,DE

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- Catalog Number : 100.13

Device Description : The OTSC System Set consists of a clip preloaded onto an application cap • a h The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 100.14

Device Description : The OTSC System Set consists of a clip preloaded onto an application cap • a h The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 100.27

Device Description : The OTSC System Set consists of a clip preloaded onto an application cap • a h The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.10

Device Description : The OTSC Anchor is one of the OTSC application aids • can be used for treating The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System

Device Class : 2

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.44

Device Description : The OTSC Twin Grasper is one of the OTSC application aids • facilitates the ap The OTSC Twin Grasper is one of the OTSC application aids • facilitates the approximation of gaping edges of a lesion before release of the OTSC clip • two jaws which can be opened separately (two grasping forceps in one device) • working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System

Device Class : 2

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.45

Device Description : The OTSC Twin Grasper is one of the OTSC application aids • facilitates the ap The OTSC Twin Grasper is one of the OTSC application aids • facilitates the approximation of gaping edges of a lesion before release of the OTSC clip • two jaws which can be opened separately (two grasping forceps in one device) • working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System

Device Class : 2

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.60

Device Description : OTSC Proctology is an innovative clipping system to be applied in proctology pro OTSC Proctology is an innovative clipping system to be applied in proctology procedures • it is used for wall closure in the anorectum (e.g. fistulae) • offers three unique advantages: large volume of tissue secured high stability at the lesion site minimal strain on surrounding tissue • exceptional properties and therapeutic functions are based on its special design and material: superelastic Nitinol • material is biocompatible, can be applied as a long-term implant • absorbable U-shaped sutures or the OTSC Proctology Anchor may be used to place the applicator cap precisely on the lesion

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1

Device Description : The OTSC Proctolgy Anchor is one of the OTSC application aids and can be used fo The OTSC Proctolgy Anchor is one of the OTSC application aids and can be used for treating a lesion before release of the OTSC Proctology clip • it can be used with the OTSC Proctology for grasping and manipulation of tissue in the anorectum • using when the application area of the OTSC Proctology clip cannot be reached with sutures • the head of the instrument is made of Nitinol

Device Class : 2

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 200.11

Device Description : The OTSC Anchor 220tt is one of the OTSC application aids • can be used for tr The OTSC Anchor 220tt is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System

Device Class : 2

Duns Number: 344007369

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

- Catalog Number : 100.28

Device Description : The OTSC System Set consists of a clip preloaded onto an application cap • a h The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant

Device Class : 2

Duns Number: 344007369

Premarket Exempt : No

Product Code : PKL

Prescription Use : Yes

Device Count : 1